Andrew S. Little, Daniel Kelly, John Milligan, Chester Griffiths, Gail Rosseau, Daniel M. Prevedello, Ricardo Carrau, Heidi Jahnke, Charlene Chaloner, Judith O'Leary, Kristina Chapple, Peter Nakaji and William L. White
Patient-reported quality-of-life (QOL) end points are becoming increasingly important health care metrics. To date, no nasal morbidity instrument specifically designed for patients undergoing endonasal skull base surgery has been developed. In this study, the authors describe the development and validation of a site-specific nasal morbidity instrument to assess patient-reported rhinological outcomes following endonasal skull base surgery.
Eligible patients included those with planned endonasal transsphenoidal surgery for sellar pathology identified in outpatient neurosurgical clinics of 3 skull base centers from October 2011 to July 2012. An initial 23-question pool was developed by subject matter experts, review of the literature, and from the results of a previous validation study to assess for common rhinological complaints. Symptoms were ranked by patients from “No Problem” to “Severe Problem” on a 6-point Likert scale. Exploratory factor analysis, change scores, and importance rank were calculated to define the final instrument consisting of 12 items (The Anterior Skull Base Nasal Inventory-12, or ASK Nasal-12). Psychometric validation of the final instrument was performed using standard statistical techniques.
One hundred four patients enrolled in the study. All patients completed the preoperative survey and 100 patients (96%) completed the survey 2–4 weeks after surgery. Internal consistency of the final instrument was 0.88. Concurrent validity measures demonstrated a strong correlation between overall nasal functioning and total scores (p < 0.001). Test-retest reliability measures demonstrated a significant intraclass correlation between responses (p < 0.001). Effect size as calculated by standardized response mean suggested a large effect (0.84). Discriminant validity calculations demonstrated that the instrument was able to discriminate between preoperative and postoperative patients (p < 0.001).
This prospective study demonstrates that the ASK Nasal-12 is a validated, site-specific, unidimensional rhinological outcomes tool sensitive to clinical change. It can be used in conjunction with multidimensional QOL instruments to assess patient-reported nasal perceptions in endonasal skull base surgery. This instrument is being used as a primary outcome measure in an ongoing multicenter nasal morbidity study. Clinical trial registration no.: NCT01504399 (ClinicalTrials.gov).
Andrew S. Little, Daniel F. Kelly, William L. White, Paul A. Gardner, Juan C. Fernandez-Miranda, Michael R. Chicoine, Garni Barkhoudarian, James P. Chandler, Daniel M. Prevedello, Brandon D. Liebelt, John Sfondouris, Marc R. Mayberg and for the TRANSSPHER Study Group
Many surgeons have adopted fully endoscopic over microscopic transsphenoidal surgery for nonfunctioning pituitary tumors, although no high-quality evidence demonstrates superior patient outcomes with endoscopic surgery. The goal of this analysis was to compare these techniques in a prospective multicenter controlled study.
Extent of tumor resection was compared after endoscopic or microscopic transsphenoidal surgery in adults with nonfunctioning adenomas. The primary end point was gross-total tumor resection determined by postoperative MRI. Secondary end points included volumetric extent of tumor resection, pituitary hormone outcomes, and standard quality measures.
Seven pituitary centers and 15 surgeons participated in the study. Of the 530 patients screened, 260 were enrolled (82 who underwent microscopic procedures, 177 who underwent endoscopic procedures, and 1 who cancelled surgery) between February 2015 and June 2017. Surgeons who used the microscopic technique were more experienced than the surgeons who used the endoscopic technique in terms of years in practice and number of transsphenoidal surgeries performed (p < 0.001). Gross-total resection was achieved in 80.0% (60/75) of microscopic surgery patients and 83.7% (139/166) of endoscopic surgery patients (p = 0.47, OR 0.8, 95% CI 0.4–1.6). Volumetric extent of resection, length of stay, surgery-related deaths, and unplanned readmission rates were similar between groups (p > 0.2). New hormone deficiency was present at 6 months in 28.4% (19/67) of the microscopic surgery patients and 9.7% (14/145) of the endoscopic surgery patients (p < 0.001, OR 3.7, 95% CI 1.7–7.7). Microscopic surgery cases were significantly shorter in duration than endoscopic surgery cases (p < 0.001).
Experienced surgeons who performed microscopic surgery and less experienced surgeons who performed endoscopic surgery achieved similar extents of tumor resection and quality outcomes in patients with nonfunctioning pituitary adenomas. The endoscopic technique may be associated with lower rates of postoperative pituitary gland dysfunction. This study generally supports the transition to endoscopic pituitary surgery when the procedure is performed by proficient surgeons, although both techniques yield overall acceptable surgical outcomes.
■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: prospective cohort trial; evidence: class III.
Clinical trial registration no.: NCT02357498 (clinicaltrials.gov)
Andrew S. Little, Daniel F. Kelly, John Milligan, Chester Griffiths, Daniel M. Prevedello, Ricardo L. Carrau, Gail Rosseau, Garni Barkhoudarian, Heidi Jahnke, Charlene Chaloner, Kathryn L. Jelinek, Kristina Chapple and William L. White
Despite the widespread adoption of endoscopic transsphenoidal surgery for pituitary adenomas, the sinonasal quality of life (QOL) and health status in patients who have undergone this technique have not been compared with these findings in patients who have undergone the traditional direct uninostril microsurgical technique. In this study, the authors compared the sinonasal QOL and patient-reported health status after use of these 2 surgical techniques.
The study design was a nonblinded prospective cohort study. Adult patients with sellar pathology and planned transsphenoidal surgery were screened at 4 pituitary centers in the US between October 2011 and August 2013. The primary end point of the study was postoperative patient-reported sinonasal QOL as measured by the Anterior Skull Base Nasal Inventory–12 (ASK Nasal-12). Supplementary end points included patient-reported health status estimated by the 8-Item Short Form Health Survey (SF-8) and EuroQol (EQ)-5D-5L instruments, and sinonasal complications. Patients were followed for 6 months after surgery.
A total of 301 patients were screened and 235 were enrolled in the study. Of these, 218 were analyzed (111 microsurgery patients, 107 endoscopic surgery patients). Demographic and tumor characteristics were similar between groups (p ≥ 0.12 for all comparisons). The most common complication in both groups was sinusitis (7% in the microsurgery group, 13% in the endoscopic surgery group; p = 0.15). Patients treated with the endoscopic technique were more likely to have postoperative nasal debridements (p < 0.001). The ASK Nasal-12 and SF-8 scores worsened substantially for both groups at 2 weeks after surgery, but then returned to baseline at 3 months. At 3 months after surgery, patients treated with endoscopy reported statistically better sinonasal QOL compared with patients treated using the microscopic technique (p = 0.02), but there were no significant differences at any of the other postoperative time points.
This is the first multicenter study to examine the effect of the transsphenoidal surgical technique on sinonasal QOL and health status. The study showed that surgical technique did not significantly impact these patient-reported measures when performed at high-volume centers.
Clinical trial registration no.: NCT01504399 (clinicaltrials.gov).
Andrew S. Little, Daniel Kelly, John Milligan, Chester Griffiths, Daniel M. Prevedello, Ricardo L. Carrau, Gail Rosseau, Garni Barkhoudarian, Bradley A. Otto, Heidi Jahnke, Charlene Chaloner, Kathryn L. Jelinek, Kristina Chapple and William L. White
Despite the increasing application of endoscopic transsphenoidal surgery for pituitary lesions, the prognostic factors that are associated with sinonasal quality of life (QOL) and nasal morbidity are not well understood. The authors examine the predictors of sinonasal QOL and nasal morbidity in patients undergoing fully endoscopic transsphenoidal surgery.
An exploratory post hoc analysis was conducted of patients who underwent endoscopic pituitary surgery and were enrolled in a prospective multicenter QOL study. End points of the study included patient-reported sinonasal QOL and objective nasal endoscopy findings. Multivariate models were developed to determine the patient and surgical factors that correlated with QOL at 2 weeks through 6 months after surgery.
This study is a retrospective review of a subgroup of patients studied in the clinical trial “Rhinological Outcomes in Endonasal Pituitary Surgery” (clinical trial no. NCT01504399, clinicaltrials.gov). Data from 100 patients who underwent fully endoscopic transsphenoidal surgery were included. Predictors of a lower postoperative sinonasal QOL at 2 weeks were use of nasal splints (p = 0.039) and female sex at the trend level (p = 0.061); at 3 months, predictors of lower QOL were the presence of sinusitis (p = 0.025), advancing age (p = 0.044), and use of absorbable nasal packing (p = 0.014). Health status (multidimensional QOL) was also predictive at 2 weeks (p = 0.001) and 3 months (p < 0.001) and was the only significant predictor of sinonasal QOL at 6 months (p < 0.001). A Kaplan-Meier analysis was performed to study time to resolution of nasal crusting, mucopurulence, and synechia as observed during nasal endoscopy after surgery. The mean time (± SEM) to absence of nasal crusting was 16.3 ± 2.1 weeks, mucopurulence was 6.2 ± 1.1 weeks, and synechia was 4.4 ± 0.5 weeks. Use of absorbable nasal packing was associated with more severe mucopurulence.
Sinonasal QOL following endoscopic pituitary surgery reaches a nadir at 2 weeks and recovers by 3 months postoperatively. Use of absorbable packing and nasal splints, while used in a minority of patients, negatively correlates with early sinonasal QOL. Sinonasal QOL and overall health status are well correlated in the postoperative period, suggesting the important influence of sinonasal QOL on the patient experience.